MAUDE Adverse Event Report: MAKO SURGICAL CORP. MCK FEMORAL-LM-RL-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 180503

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Pain (1994)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Original date of surgery was (b)(6) 2015.Patient presented with pain during a follow up appointment.Doctor said patient was revised to a tka for possible aseptic loosening and no radiolucent lines on x-ray.

Manufacturer Narrative

An event regarding loosening involving an mako femoral component was reported.The event was not confirmed.Method & results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: no medical records or x-rays were made available for evaluation.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

Original date of surgery was (b)(6) 2015.Patient presented with pain during a follow up appointment.Doctor said patient was revised to a tka for possible aseptic loosening and no radiolucent lines on x-ray.

• Brand Name: MCK FEMORAL-LM-RL-SZ 3
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5808193
• MDR Text Key: 49963873
• Report Number: 3005985723-2016-00225
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 180503
• Device Lot Number: 237299K-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR